Indications and uses
■ temporary relief of the following cold symptoms. ■ sore throat ■ minor aches and pains ■ headache ■ fever ■ nasal congestion ■ sinus congestion and pressure ■ cough
■ temporary relief of the following cold symptoms. ■ sore throat ■ minor aches and pains ■ headache ■ fever ■ nasal congestion ■ sinus congestion and pressure ■ cough
■ adults and children 15 years and older: take 2 capsules after a meal 2 times a day ■ Do not take more than directed ■ children under 15 years: do not use and ask a doctor.
Acetaminophen 200mg ………………………………………………………….………………pain reliever /fever reducer
Guaifenesin 35mg…………………………………………………………………………….……...expectorant
Phenylephrine HCl 5mg……………………….……………………………………………....….nasal decongestant
Dextromethorphan HBr 8mg…………………………………………………cough suppression
Diphenhydramine HCl 15mg………………………………………………..antihistamine
purified water, polyethylene glycol 400, propylene glycol, gelatin, povidone, sorbitol, gardenia blue
■ temporary relief of the following cold symptoms. ■ sore throat ■ minor aches and pains ■ headache ■ fever ■ nasal congestion ■ sinus congestion and pressure ■ cough
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets in 24 hours. Severe liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
Relief cold symptoms and minor pains.
■ adults and children 15 years and older: take 2 capsules after a meal 2 times a day ■ Do not take more than directed
■ children under 15 years: do not use and ask a doctor.
you have ■ allergic reaction ■ asthma ■ liver disease ■ pregnant or breast feeding ■ medical care ■ glaucoma ■ high blood pressure ■ thyroid disease ■ heart disease ■ diabetes
■ taking sedatives or tranquilizers ■ having chicken fox or other infections
■ taking the blood thinning drug warfarin
■ For children who are younger than 3 months old. (new born baby)
■ If you ever had an allergic reaction to this product or any of its ingredients.
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
■ If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease) or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist)
Do not take this drug and ask a health professional
1-562-695-2818 Monday - Friday 9AM-5PM WET
Distributed by: Bio Mission Group Inc.
■ nervousness, dizziness, or sleeplessness, constipation occurs
■ redness or swelling is present ■ fever get worse or lasts more than 3 days
■ new severe symptoms occur such as shock (anaphylaxis), Stevens Johnson Syndrome, Lyell Syndrome, Asthma, Dyshepatia or Interstitial lung diseases.
■ pain, cough, nasal congestion gets worse or lasts after 5-6 times of taking a dose.
■ Do not exceed recommended dose. Do not drink when taking doses
■ Avoid drive or use of machineries.
■ Store between room temperature 20-25°C (68-77°F)
■ Avoid direct light or humid condition and excessive heat
Do not exceed recommended dose. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-333-2333).
NDC 69365-003-01
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Facol Cold & Flu Night
MULTI
Soft liquid-filled capsule
Guaifenesin-Expectorant
Acetaminophen-Fever/pain reliever
Phenylephrine HCl-Nasal Decongestant
Dextromethorphan HBr- Cough Suppressant
Diphenhydramine HCl-Antihistamine
sleep aid
10 capsules
JW Pharmaceuticals
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1664631 | acetaminophen 200 MG / dextromethorphan hydrobromide 8 MG / diphenhydrAMINE 18.75 MG / guaiFENesin 35 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 9 |
| 1664631 | acetaminophen 200 MG / dextromethorphan hydrobromide 8 MG / diphenhydramine 18.75 MG / guaifenesin 35 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 9 |
| 1664631 | APAP 200 MG / Dextromethorphan Hydrobromide 8 MG / Diphenhydramine 18.75 MG / Guaifenesin 35 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 9 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69365-003-01 | 2025-07-29 | C162847 | 48780-1 | 1030e365-58c6-111a-e063-dadaa90a10e2 | FACOL COLD AND FLU NIGHT |
| 69365-003-01 | 2024-08-29 | C162847 | 48780-1 | 1030e365-58c6-111a-e063-dadaa90a10e2 | FACOL COLD AND FLU NIGHT |
| 69365-003-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-58c6-111a-e063-dadaa90a10e2 | FACOL COLD AND FLU NIGHT |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69365-003-01 | Facol Cold and Flu Night | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 9 | |
| 69365-003-01 | Facol Cold and Flu Night | 1 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 1 | 9 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69365-003 | FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] | 9 | Legacy NDC, 2 package rows | 20240830_104a3cba-6eb2-48b3-e054-00144ff8d46c.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 2 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 2 | |
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 2 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 2 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 2 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 2 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 2 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 2 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 2 | |
| GARDENIAN BLUE | INACTIVE INGREDIENT | 54A6568109 | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 2 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69365-003 | 69365-003-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| GARDENIAN BLUE | 54A6568109 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| WATER | 059QF0KO0R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POVIDONE K29/32 | 390RMW2PEQ | IACT |
| GELATIN | 2G86QN327L | IACT |
| SORBITOL | 506T60A25R | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAVENOUS | 28216 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / TOPICAL | 6300 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION, SOLUTION / INTRAVENOUS | 24186 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | EMULSION / TOPICAL | 1.2 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 14 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / PERIODONTAL | 3.44 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / SUBLINGUAL | 19 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUPPOSITORY / VAGINAL | 252 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET / ORAL | 193 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / SUBCUTANEOUS | 16 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | LIQUID / TOPICAL | 1 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / SUBCUTANEOUS | 4.7 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | SOLUTION / ORAL | 34.8 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, LIQUID FILLED / ORAL | 1042 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / NASAL | 25 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER, FOR SUSPENSION / ORAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, DELAYED RELEASE / ORAL | 26 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | AEROSOL, POWDER / TOPICAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / BUCCAL | 5110 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 14 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, COATED / ORAL | 42.12 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | LOTION / TOPICAL | 5 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SWAB / TOPICAL | 5250 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / ORAL | 337.28 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAMUSCULAR | 406 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER / ORAL | 100 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 20ba65ce-d61f-0f56-e063-6394a90a019d | 104a3cba-6eb2-48b3-e054-00144ff8d46c | 2024-08-28 | Warnings | 20ba65ce-d61f-0f56-e063-6394a90a019d 104a3cba-6eb2-48b3-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.